ANCHOR TRIAL

Anti-VEGF antibody for the treatment of predominantly

classic choroidal neovascularisation in AMD (ANCHOR)

by Dr. Hasan Usmani

Method

· Phase III, randomised, multi-centre double-masked active treatment-controlled trial

· Comparing two different doses of Ranibizumab to verteporfin photodynamic therapy (PDT) in treating subfoveal neovascular macular degeneration.

· 423 patients in the United States, Europe and Australia

· Randomised 1:1:1 to either PDT plus sham injection or to placebo PDT plus Ranibizumab (0.3 mg or 0.5 mg) monthly for 24 months.

· Fluorescein angiography every three months to determine the need for additional PDT or placebo PDT

Inclusion criteria

· patients with predominantly classic CNV

· VA 6/12 – 6/96

Primary endpoint

· Proportion of subjects losing less than 15 ETDRS letters at one year.

Secondary endpoint

· Change in VA from baseline

Results

· Maintaining vision: patients losing fewer than 15 letters at 12 months

o 94% in Ranibizumab 0.3 mg vs. 96% in Ranibizumab 0.5 mg vs. 64% in PDT group (p < 0.0001)

· Improving vision: patients gaining 15 letters or more

o 36% (Ranibizumab 0.3 mg) vs. 40% (Ranibizumab 0.5 mg) vs. 6% (PDT) (p < 0.0001)

· Other findings:

o Average number of letters gained or lost

· 9 letters gained (Ranibizumab 0.3 mg) vs. 11 letters gained (Ranibizumab 0.5 mg) vs. 10 letters lost PDT (p< 0.0001)

o Severe visual loss

· 0% Ranibizumab vs.13% PDT

o Change in leakage on FFA

· Decreased by average 2 disc areas (DA) in Ranibizumab vs. increased by average 1/3 DA in PDT (p < 0.0001)

Adverse events

· Endophthalmitis

· 0% in 0.3mg Ranibizumab vs. 1.4% in 0.5mg Ranibizumab

· Uveitis

· 10.2% in 0.3mg Ranibizumab vs.15% in 0.5mg Ranibizumab vs. 2.8% in PDT

· Non-ocular vascular events

· 2.2.% in 0.3mg Ranibizumab vs. 4.3% in 0.5 mg Ranibizumab vs. 2.1% in PDT